说明与适用边界
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spl product data elements
Sleep Aid Nighttime Diphenhydramine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE FD&C BLUE NO. 1 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED LECITHIN, SOYBEAN WATER SORBITOL SORBITAN LIGHT MINERAL OIL MANNITOL PC5
活性成分 / Active ingredient
Active ingredient (in each softgel) Diphenhydramine HCl 50 mg
用途 / Purpose
Purpose Nighttime sleep-aid
适应证 / Indications and usage
Use For relief of occasional sleeplessness.
警告 / Warnings
Warnings Do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product avoid alcoholic drinks. Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away
禁用事项 / Do not use
Do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin
咨询医生 / Ask a doctor
Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland
咨询医药人员 / Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
使用中 / When using
When using this product avoid alcoholic drinks.
停用事项 / Stop use
Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
孕哺期 / Pregnancy or breastfeeding
If pregnant or breast-feeding, ask a health professional before use.
儿童安全 / Keep out of reach of children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away
用法用量原文 / Dosage and administration
Directions adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor
其他安全资料 / Other safety information
Other information store between 15-30ºC (59-86ºF)
辅料 / Inactive ingredients
Inactive ingredients FD&C blue #1, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, purified water, sorbitol, sorbitan, white ink
questions
Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
package label principal display panel
Principal Display Panel Compare to Unisom® SleepGels® active ingredient* Maximum Strength† SLEEP-AID Diphenhydramine HCl, 50 mg Nighttime Sleep-Aid Fall Asleep Fast SOFTGELS (ONE SOFTGEL PER DOSE) †Under OTC monograph. *This product is not manufactured or distributed by Sanofi Consumer Healthcare NA, distributor of Unisom® SleepGels®. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
Product Label CVS Maximum Strength Sleep-Aid Diphenhydramine HCl 50 mg
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 10 / 20260511
- 获取时间
- 2026-10-08
- 许可
- openFDA public data; retain original label attribution. See 查看来源 and dataset source notices. Public access does not imply approval or unrestricted rights to every submitted label.